CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 157 enrolled
Drug / intervention
etravirine (ETR, TMC125) +1 moredrug
Likely dose
etravirine (ETR, TMC125) 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00903682
NCT00903682Phase 2Completed
CompareCT.gov

A Phase IIb, Multi-centre, Randomised, Double-blind, Active-controlled Trial Comparing the Neuropsychiatric Adverse Event Profile of Etravirine 400mg qd Versus Efavirenz 600mg qd in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in ARV Therapy-naive HIV-1 Infected Subjects

Janssen-Cilag International NV·interventional·Posted May 18, 2009·Updated Jan 14, 2013

In Brief

A Phase 2 clinical trial evaluating etravirine (ETR, TMC125) and efavirenz (EFV) for HIV Infection and 2 related conditions. Completed, enrolled 157 participants across 33 sites in 11 countries.

Detailed Summary

The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed throughout the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection, HIV, Acquired Immunodeficiency Syndrome
CountriesAustria, Denmark, France, Germany, Hungary, Israel, Romania, Russia, Spain, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2009
Enrollment StartJun 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.1 years ago

Interventions

etravirine (ETR, TMC125)drug

400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks

efavirenz (EFV)drug

600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks